An Official Request for Help

[Katie]

So here's some background with questions below:

I just spent the last three days traveling to yet another surgeon. This one was in province and had a good reputation for cervical ADR, and the only reason I went to see him was because after a six month wait, he had a cancellation and could see me at short notice.

He was basically my last chance to find one in my province who would recommend out of country surgery, specifically to travel to Stenum to get the M6 from Spinal Kinetics, the only device to which I'm not allergic (it seems).

He would only discuss my cervical levels, not my lumbar. He is one of the few here in Canada who does ADR, but not in the lumbar levels.

Not only did he refuse to do that, but he said that he did not recommend any surgery on my cervical levels, despite the fact that Dr. Bitan regarded it as an emergency. His opinion was that American doctors tend to over dramatize the problems and do too many surgeries too often. He considered himself more conservative. Why is it that only Canadian (Ontario?) doctors are so conservative? Germans, etc. are apparently too aggressive too

He would only recommend surgery in a case like mine if I was much more incapacitated; I have to be unable to get around on my own or bodily functions must be more impaired (complete incontinence, etc.) Quality of life does not balance out the risk involved, he says. Even when he admits that I will not recover any functions that I've already lost, just prevent more. If I still insisted, he would take bone from my hip and try to fuse it without any hardware, requiring a hard neck collar for three months. Not my cup of tea....and it still doesn't address my extremely painful lumbar.

Sooooooooo, here's the deal. The previous surgeon in another province is still willing to 'play'. (You may need to refresh yourself with my novel ; he was going to do four levels just two weeks ago until I discovered my allergies)

But I have to find an appropriate device that is only made of pure Titanium, or surgical grade Titanium covered with pure Titanium (or Titanium Nitride). When surgeons speak of Titanium, they usually mean
surgical grade, which has 90% pure, plus 6% Vanadium and 4% Aluminum, an alloy of those three metal mixed together. I am severely allergic to the Aluminum only in that mixture. There's no way of knowing if/when that Aluminum will leach out, but if it does, I have no other options once it's in there.

Or the device has to be made of some other material like ceramic, polymer, etc. I wondered about two levels of fusion and then one like that for example? I haven't been able to find such a device yet though.

The M6 has endplates that have pure Titanium where they embed into the bone, and there are only small areas on the top and bottom side edges (that are not subject to wear) that are made of surgical 'T'.

I would take my chances with that disc. One of the top persons at M6 believes that it should be safe, as does the lab where I had my testing done. I have spent several hours talking to them. No one can promise anything of course, but the odds are in my favour on this.

Question #1 Are there any engineers out there who would offer another opinion, for or against, on the slim chance that I can somehow convince the insurance to let me go to Stenum for this?

If not, here's the second thing I need help with.....

We will need to either make a custom disc, or find one that has so far elluded me.

Is there anyone out there that knows of such a device? Plus hardware for fusion? My surgeon said he will go along with any suitable device I find, but I am striking out.

He also refuses (thankfully) to do three levels of fusion. His experience has been that they all fail within five years. He was planning on a hybrid, two fusions and one ADR at L3 to S1, and an either/or at C5/6 depending on what he found when he went in.

I need help with finding a device. I'm not smart enough to have investigated every one out there, although I've given it my best go. Has anyone out there come across something suitable?

Just to simplify...I am severely allergic to Aluminum, Iron, Nickel, Cobalt, Chromium, Cadmium and Molybdenum. The lab at Duke University has never seen anyone with this number of allergies before, or the severity of the reaction. (Yeah! )

Thanks for any feedback here. I'm exhausted and tired of hitting brick walls. And sorry for the length...again.

[daveinaustin]

I am a Sr. Computer Engineer, focusing on SW / HW interfacing in the test and measurement industry. Note that I am not a Mechanical Engineer. Please take my advice with a grain of salt. However, I know a few things about material strain and testing. Also, for your case, my reply is very conservative.

The purpose of my reply is only to try to help you think through a very difficult decision for you to make. Unfortunately, I don't have a perfect answer, and sincerely wish I did.

One of the top persons at M6 believes that it should be safe

As an Engineer, that nothing scares me more than the words "x should be safe." I constantly hear that in my field, and often find issues. Of course, that's part of my job is to assess risk within my group's projects. However, we are talking about your life!

The M6 looks like an amazing device. However, one issue that you know is that Polyethylene is prone to cracking and wear, even after a matter of weeks. Due to your allergies, you need to know all materials that are within its annulus, as well as the viscous polymer within its nucleus.

If all of the metal within the M6 is pure Titanium, that's great news, since I believe that any composite alloy metal can be prone to leakage into soft tissue. However, I'm not a Materials Engineer.

Personally, if I had as bad of metallic allergies as you do, I would worry for the rest of my life if I did not know exactly every metal and polymer within each of the M6 components. The M6 seems great, but it is very complex, and comprised with many materials. Unfortunately, I know of no other ADR that would be better.

Obviously, the Prodisc-C is not an option since there have been signs of minor cracking and metal leakage within soft tissue within 12 weeks of implant.

Alternative: Have you are your doctors determined whether Fibrin sealant could help one or more levels?

I sincerely wish the best for you with this most difficult decision.

-Dave

[DanielleP924]

So here's some background with questions below:

I just spent the last three days traveling to yet another surgeon. This one was in province and had a good reputation for cervical ADR, and the only reason I went to see him was because after a six month wait, he had a cancellation and could see me at short notice.

He was basically my last chance to find one in my province who would recommend out of country surgery, specifically to travel to Stenum to get the M6 from Spinal Kinetics, the only device to which I'm not allergic (it seems).

He would only discuss my cervical levels, not my lumbar. He is one of the few here in Canada who does ADR, but not in the lumbar levels.

Not only did he refuse to do that, but he said that he did not recommend any surgery on my cervical levels, despite the fact that Dr. Bitan regarded it as an emergency. His opinion was that American doctors tend to over dramatize the problems and do too many surgeries too often. He considered himself more conservative. Why is it that only Canadian (Ontario?) doctors are so conservative? Germans, etc. are apparently too aggressive too

He would only recommend surgery in a case like mine if I was much more incapacitated; I have to be unable to get around on my own or bodily functions must be more impaired (complete incontinence, etc.) Quality of life does not balance out the risk involved, he says. Even when he admits that I will not recover any functions that I've already lost, just prevent more. If I still insisted, he would take bone from my hip and try to fuse it without any hardware, requiring a hard neck collar for three months. Not my cup of tea....and it still doesn't address my extremely painful lumbar.

Sooooooooo, here's the deal. The previous surgeon in another province is still willing to 'play'. (You may need to refresh yourself with my novel ; he was going to do four levels just two weeks ago until I discovered my allergies)

But I have to find an appropriate device that is only made of pure Titanium, or surgical grade Titanium covered with pure Titanium (or Titanium Nitride). When surgeons speak of Titanium, they usually mean
surgical grade, which has 90% pure, plus 6% Vanadium and 4% Aluminum, an alloy of those three metal mixed together. I am severely allergic to the Aluminum only in that mixture. There's no way of knowing if/when that Aluminum will leach out, but if it does, I have no other options once it's in there.

Or the device has to be made of some other material like ceramic, polymer, etc. I wondered about two levels of fusion and then one like that for example? I haven't been able to find such a device yet though.

The M6 has endplates that have pure Titanium where they embed into the bone, and there are only small areas on the top and bottom side edges (that are not subject to wear) that are made of surgical 'T'.

I would take my chances with that disc. One of the top persons at M6 believes that it should be safe, as does the lab where I had my testing done. I have spent several hours talking to them. No one can promise anything of course, but the odds are in my favour on this.

Question #1 Are there any engineers out there who would offer another opinion, for or against, on the slim chance that I can somehow convince the insurance to let me go to Stenum for this?

If not, here's the second thing I need help with.....

We will need to either make a custom disc, or find one that has so far elluded me.

Is there anyone out there that knows of such a device? Plus hardware for fusion? My surgeon said he will go along with any suitable device I find, but I am striking out.

He also refuses (thankfully) to do three levels of fusion. His experience has been that they all fail within five years. He was planning on a hybrid, two fusions and one ADR at L3 to S1, and an either/or at C5/6 depending on what he found when he went in.

I need help with finding a device. I'm not smart enough to have investigated every one out there, although I've given it my best go. Has anyone out there come across something suitable?

Just to simplify...I am severely allergic to Aluminum, Iron, Nickel, Cobalt, Chromium, Cadmium and Molybdenum. The lab at Duke University has never seen anyone with this number of allergies before, or the severity of the reaction. (Yeah! )

Thanks for any feedback here. I'm exhausted and tired of hitting brick walls. And sorry for the length...again.

Katie-

Wow, and I thought I had problems with my back. My heart totally goes out to you and what you are living through. You must be so miserable and in so much pain. And then to have all the stress of trying to find your own device for surgery sounds horrible.

Why aren't your doctors trying to find the appropriate device to implant in your spine? I don't understand why you should be the one doing all the research. Seems like it should be the responsibility of the doctors involved, not yours.

I wish you all the luck in finding some sort of pain resolution.

DanielleP924

[Katie]

Danielle, thanks for your kind thoughts. As for your question about my doctor's involvement in finding a device for me, the answer has more to do with hours in the day than anything else, I believe.

He is one of a handful of surgeons who do ADR surgery here in Canada, and in huge demand. He was all set to do a four level surgery on me, but simply doesn't have the time to do the research needed for this new problem.

My hope is that he has gone to his International colleagues at a major conference in San Francisco last week and tossed this problem around with them. I did point out that he would probably end up in a Medical Journal if he could solve this special issue So I hope I was the topic of conversation at least once!

So far, he is the only one who is willing to work with me. Dr. Bitan has not responded at all, and all others have washed their hands of me here, saying I am not a surgical candidate. I'm hoping to hear from my present one next week and talk over the options. At least he's still talking

This trip was pretty bad, pain wise. It's been awhile since I've been unable to control the pain. The tears were just running down my face while I was in the hotel bed; I was afraid to take any more morphine but was in agony with a fair bit more than my normal dose. Road trips are just not much fun, but I loved the one on one company I had with my hubby.

Dave, you raised some interesting points, especially about the polymers etc of the M6. I didn't want to put words in the mouth of the M6 rep. He was careful to say that he wasn't a doctor and couldn't give advice, but explained every bit of the metal issues that I had. He was extremely generous with his time.

No one will guarantee anything, of course. I put the polymer questions aside right now and concentrated on the metal allergies, but you are very correct to bring me back to those as well. There's a bit of the ostrich syndrome going on with that

As I mentioned somewhere, the M6 only has pure Titanium in the end plate. The rest of the appliance is made of surgical grade Titanium. Which means that it could be prone to leakage of the other metal ions. My problem is that I don't have enough Mechanical Engineering knowledge to understand how the alloys work; how the different ions can 'escape' and move into my bloodstream.

The University lab would only say that the Titanium breaks down into particles, not ions like the other metals. So if they are mixed with Aluminum and Vanadium, how do those other two metal ions react when they come in contact with my tissue? Only the top ridge/edge of the M6 exposes me to the surgical grade, the rest is covered with the polymer. That edge is not in a spot where it should 'wear', or rub. Theoretically it should not break down easily and release the Aluminum ions. Theoretically......

I've sent you a PM and would like to discuss this at length, where I don't have to sit to type. If you or anyone else has the oomph to go further with this discussion, I would be very happy.

Thanks again.

[Justin]

Katie,

Sorry about your appointment and painful travels. I received this information from a friend regarding some possible fusion hardware that might be applicable in your situation:

If I needed a cervical fusion I would look to have Cervical PEEK with some type of Synthetic Bone Graft like NovaBone or Apatech, in a traditional sense, the PEEK would be augmented by a Cervical Plate.

Today there are various companies that offer combo products (PEEK and Plate attached to one another) like Synthes Zero-P, Globus Coalition, Spinal Elements, etc... One question, does this person have posterior degeneration? If so, they will probably need some type of Posterior Cervical Fixation...

In terms of an artificial disc that works despite your severe metal allergies: I think you will have to have one specifically designed for your situation. Specifically designing a disc has its own potential hurdles as well (cost, "inferior" design based on different materials used, the nature and extent of materials / device testing will most likely be limited, etc.).

Good luck and I am sorry that you are hitting your head against a brick wall again.

Hang in there.

[Terry Newton]

It sounds like Stenum is the absolute best option.

Hang in there.

[Katie]

Terry, I agree, except for the possibilities that Dave mentioned...whether anything in the polymer levels would bother me, allergy wise. I don't know enough about what is in them, and would have to have yet another test done once we found the contents....

That and the $$$$$ of a five level surgery there are the only things stopping me

[Katie]

Justin, sorry that I pushed submit before addressing your post as well. I'm going to have to look up the models that are mentioned in the post. It's getting so confusing with all the different manufacturers.

Thankfully my surgeon is willing to go along with this research idea. He's been away for a few weeks, which I discovered today. I was beginning to get that inferiority complex again after not hearing from him for awhile .

Keep piling on the ideas, folks! Just remember what that one little post from Liz did for me....making me send away that allergy test back in August. You just never know....

[KBear]

Katie- Here's an idea... Just about all of us have surgeons who did or are doing surgery on us. We either are seeing them pre-op or post-op. How about you ask everyone to ask their surgeon/spine doctors at their next appointment if they have any ideas? I don't think the surgeon would mind, if we just mentioned during the appointment that we have a friend who needs 5 levels of cervical and lumbar; but has severe metal allergies and asked them if they knew of a suitable device?? You never know, that would be like picking 100's of dr's minds at once? Maybe one of them would have something. Just a thought....

[Katie]

Kathy, that is brilliant.

I think you just did the asking. There is a conflict among doctors I've seen as to whether I need four or five discs, whether C 4/5 needs attention as well as the C 5/6. L3 to S1 are absolutely positive after the discogram in August, but only the out-of-country surgeons, including Dr. Bitan, want to replace C 4/5 as well as all the rest.

Either way, that is a marvelous idea. Whether the surgeons will like being asked is another thing though. I barely have enough time to discuss my own problems in my appointments, let alone anyone else's, but maybe I gab too much...

Thank you for bringing this up.

There was a large convention for spine surgeons in San Francisco last week. I'm hoping my guy was there and came back with some ideas.